Uniunea Europeană - portugheză - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivacaftor, tezacaftor, elexacaftor - fibrose cística - outros produtos do sistema respiratório - kaftrio is indicated in a combination regimen with ivacaftor for the treatment of cystic fibrosis (cf) in patients aged 6 years and older who have at least one f508del mutation in the cystic fibrosis transmembrane conductance regulator (cftr) gene.

Uniunea Europeană - portugheză - EMA (European Medicines Agency)

novartis europharm limited - crizanlizumab - anemia, célula falciforme - other hematological agents - adakveo is indicated for the prevention of recurrent vaso occlusive crises (vocs) in sickle cell disease patients aged 16 years and older. it can be given as an add on therapy to hydroxyurea/hydroxycarbamide (hu/hc) or as monotherapy in patients for whom hu/hc is inappropriate or inadequate.

Uniunea Europeană - portugheză - EMA (European Medicines Agency)

theramex ireland limited - teriparatida - osteoporose - homeostase de cálcio - livogiva is indicated in adults. tratamento da osteoporose em mulheres pós-menopáusicas e em homens com risco aumentado de fratura. in postmenopausal women, a significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures have been demonstrated. tratamento da osteoporose associada com sustentado sistêmica do glicocorticóide terapia em mulheres e homens em aumento do risco de fratura.

Uniunea Europeană - portugheză - EMA (European Medicines Agency)

biosimilar collaborations ireland limited - insulina aspart - diabetes mellitus - drogas usadas em diabetes - kirsty is indicated for treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.

Uniunea Europeană - portugheză - EMA (European Medicines Agency)

biocryst ireland limited - berotralstat dihydrochloride - angioedemas, hereditário - other hematological agents - orladeyo is indicated for routine prevention of recurrent attacks of hereditary angioedema (hae) in adult and adolescent patients aged 12 years and older.

Uniunea Europeană - portugheză - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - dostarlimab - endometrial neoplasms - antineoplastic agents and antibody drug conjugates - jemparli is indicated as monotherapy for the treatment of adult patients with mismatch repair deficient (dmmr)/microsatellite instability-high (msi h) recurrent or advanced endometrial cancer (ec) that has progressed on or following prior treatment with a platinum-containing regimen.

Uniunea Europeană - portugheză - EMA (European Medicines Agency)

amarin pharmaceuticals ireland limited - icosapent ethyl - deslipidemias - agentes modificadores de lipídios - indicated to reduce cardiovascular risk as an adjunct to statin therapy.

Uniunea Europeană - portugheză - EMA (European Medicines Agency)

mylan ireland limited - acetato de abiraterona - neoplasias prostáticas - endocrine therapy, other hormone antagonists and related agents - abiraterone mylan is indicated with prednisone or prednisolone for:the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mhspc) in adult men in combination with androgen deprivation therapy (adt). the treatment of metastatic castration resistant prostate cancer (mcrpc) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated. the treatment of mcrpc in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen.

Uniunea Europeană - portugheză - EMA (European Medicines Agency)

mylan ireland limited - sugammadex sodium - bloqueio neuromuscular - todos os outros produtos terapêuticos - reversal of neuromuscular blockade induced by   rocuronium or vecuronium in adults. for the paediatric population: sugammadex is only recommended for routine reversal of rocuronium induced blockade in children and adolescents aged 2 to 17 years.

Uniunea Europeană - portugheză - EMA (European Medicines Agency)

immunocore ireland limited - tebentafusp - uveal neoplasms - agentes antineoplásicos - kimmtrak is indicated as monotherapy for the treatment of human leukocyte antigen (hla)-a*02:01-positive adult patients with unresectable or metastatic uveal melanoma.